Medical device licence · 105607 · Class 2
DXH 560
Yes: licensed in Canada
Licence status Issued (active); first licensed December 10, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105607
- Licence holder
- Beckman Coulter Ireland, Inc.Co. Clare, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 10, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DXH 500 SERIES CALIBRATOR
- DXH 500 SERIES CLEANER
- DXH 500 SERIES CONTROL
- DXH 500 SERIES DILUENT
- DXH 500 SERIES LYSE
- DXH 560
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.